SUKL Bulletin 4/2009

Since 2009 SUKL Bulletin is published in electronic form. Full version is available on the czech webpage.

Contents:

  • Measures taken in the case of quality defects or adverse reactions to medicinal productsin the month of March 2009
  • List of guidelines valid as of April 1, 2009
  • Outcomes of projects finished by the Laboratory Control Section
  • Announcement on commencement of competition for the lowest price
  • Medicinal products containing pseudoephedrine have been switched to a new category of supplyof medicinal products, “OTC medicinal products subject to sales restriction”
  • Outline of notifications on the use of non-authorised medicinal products in the month of March 2009
  • List of authorised medicinal products where placing on the market of individual batches with the labellingin a foreign language was approved in the month of March 2009
  • List of medicinal products whose authorisation for parallel import was granted in the month of March 2009
  • Information on documents issued by the European Medicines Agency (EMEA)
  • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
  • Data on applications submitted to SUKL – marketing authorisations and variations thereto
  • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the first quarter of 2009
  • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of March 2009
  • List of medicinal products whose marketing authorisation will expire in June 2009
  • List of medicinal products with expired marketing authorisation
  • List of medicinal products for which maximum price applies in the same amount as proposed by the applicant
  • List of medicinal products for which the level and conditions of reimbursement were transferredfollowing transfer of their marketing authorisations
  • Revocations of marketing authorisations in the period from January 1, 2009 to February 18, 2009
  • Authorised medicinal products and variations to marketing authorisations approved in the year 2009
  • Medicinal products authorised under the EU centralised procedure and enteredin SUKL database in the year 2009
  • List of specific therapeutic programmes approved in the period from March 1, 2009 to March 31, 2009